Hazard Type

Software Defect Recalls

1,491 product recalls involving software defect. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

1,491Total Recalls
113Critical
36.5MUnits Affected
All Recalls

Every Software Defect Recall

Sorted by most recent. Click any recall for full details and safety information.

1,491 recalls
High RiskFDA
Philips Electronics North America Corporation
Velara Generator with an old Firmware version used with the Philips Integris BH5000
Medical Devices·59 affected·Dec 9, 2016
High RiskFDA
Polymer Technology Systems
A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
Medical Devices·500 affected·Dec 2, 2016
High RiskFDA
Polymer Technology Systems
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
Diagnostic Devices·8,285 affected·Dec 2, 2016
High RiskFDA
Polymer Technology Systems
A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058
Medical Devices·112,648 affected·Dec 2, 2016
High RiskFDA
Perkinelmer Health Sciences, Inc.
Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use ...
Medical Devices·21 affected·Dec 1, 2016
High RiskFDA
Carestream Health Inc
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or flu...
Diagnostic Devices·14 affected·Nov 21, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstru...
Medical Devices·104 affected·Nov 15, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction...
Medical Devices·184 affected·Nov 12, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstructio...
Medical Devices·337 affected·Nov 12, 2016
High RiskFDA
Raysearch Laboratories Ab
RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed...
Medical Devices·66 affected·Nov 9, 2016
High RiskFDA
Olympus Corporation Of The Americas
HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
Surgical Devices·494 affected·Nov 3, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to ...
Medical Devices·7 affected·Nov 2, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to p...
Medical Devices·7 affected·Nov 2, 2016
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy System
Medical Devices·6 affected·Oct 20, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force, System x-ray, tomography, computed
Medical Devices·48 affected·Oct 20, 2016
High RiskFDA
Raysearch Laboratories Ab
Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analy...
Medical Devices·540 affected·Oct 11, 2016
High RiskFDA
Soft Computer Consultants, Inc.
SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. U...
Medical Devices·189 affected·Oct 6, 2016
High RiskFDA
Soft Computer Consultants, Inc.
Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources,...
Medical Devices·189 affected·Oct 6, 2016
High RiskFDA
Medimaps Group
TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analy...
Medical Devices·15 affected·Oct 3, 2016
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information manageme...
Medical Devices·251 affected·Sep 15, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza, Picture Archiving and Communication System
Medical Devices·47 affected·Sep 6, 2016
High RiskFDA
Novarad Corporation
NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Produc...
Medical Implants·90 affected·Aug 12, 2016
High RiskFDA
Ortho Kinematics, Inc
Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging softw...
Medical Devices·1 affected·Aug 12, 2016
High RiskFDA
Nidek Inc
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, hi...
Medical Devices·29 affected·Aug 8, 2016
High RiskFDA
Medtronic Inc.
CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro s...
Diabetes Devices·33 affected·Aug 5, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, commu...
Medical Devices·338 affected·Aug 5, 2016
High RiskFDA
Toshiba American Medical Systems Inc
Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
Diagnostic Devices·93 affected·Aug 4, 2016
High RiskFDA
Hospira Inc., A Pfizer Company
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the Sapph...
Medical Devices·20 affected·Jul 28, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the view...
Medical Devices·103 affected·Jul 26, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic tre...
Medical Devices·103 affected·Jul 26, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliv...
Medical Devices·103 affected·Jul 26, 2016
High RiskFDA
Tecan Us, Inc.
SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density)...
Diagnostic Devices·19 affected·Jul 25, 2016
High RiskFDA
Tecan Us, Inc.
Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of l...
Diagnostic Devices·5 affected·Jul 25, 2016
High RiskFDA
Ge Oec Medical Systems, Inc
OEC UroView 2800, fluoroscopic x-ray system
Medical Devices·47 affected·Jul 22, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) r...
Medical Devices·32 affected·Jul 20, 2016
High RiskFDA
Zimmer Biomet, Inc.
ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be...
Surgical Devices·18 affected·Jul 20, 2016
High RiskFDA
Medtronic Navigation, Inc.
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. ...
Medical Devices·27 affected·Jul 18, 2016
High RiskFDA
Medtronic Navigation, Inc.
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product...
Medical Devices·27 affected·Jul 18, 2016
High RiskFDA
Medtronic Navigation, Inc.
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. ...
Medical Devices·27 affected·Jul 18, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (I...
Diagnostic Devices·29 affected·Jul 14, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Medical Devices·1 affected·Jul 13, 2016
RecallFDA
Elitech Group B.v.
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated cli...
Diagnostic Devices·89 affected·Jul 12, 2016
High RiskFDA
American National Mfg Inc
Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.
Medical Devices·31 affected·Jul 11, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 1028095...
Cardiac Devices·51 affected·Jul 7, 2016
High RiskFDA
Nidek Inc
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can ...
Medical Devices·17 affected·Jul 1, 2016
High RiskFDA
Olympus Scientific Solutions Americas
Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ioniz...
Medical Devices·2 affected·Jun 22, 2016
High RiskFDA
Walkmed Infusion, Llc
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Medical Devices·2,966 affected·Jun 14, 2016
High RiskFDA
Walkmed Infusion, Llc
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Medical Devices·2,482 affected·Jun 14, 2016